Head of Quality Control
6 hours ago
Fujifilm Diosynth Biotechnologies is seeking a highly skilled and experienced Senior Director of Quality Control to lead our Quality Control Laboratories at our state-of-the-art facility in Holly Springs, North Carolina. As a key member of our site leadership team, you will be responsible for developing and implementing the Quality Control strategy, building and leading a high-performing QC team, and ensuring compliance with cGMP and regulatory requirements.
Key Responsibilities- Develop and implement the Quality Control strategy and roadmap for the Holly Springs site, aligned with the global Quality Strategy.
- Build, develop, and lead a high-performing QC team, providing clear priorities, feedback, and career development opportunities.
- Create and transition the QC department to a new state-of-the-art laboratory.
- Lead the growth and expansion of the QC team, including regional accountabilities for intra-company testing.
- Provide strategic decision-making, prioritizing deliverables to meet site and compliance objectives.
- Oversee all QC operations, including In Process Testing, Bulk Release and Stability Testing, Microbiological Testing, and Environmental and Utility Monitoring.
- Support and participate in client visits, audits, and regulatory agency inspections.
- Ensure budgets, timelines, schedules, and performance requirements are established and met.
- Assure all areas of responsibility conform to cGMP and other appropriate regulatory requirements.
- Bachelor's Degree in Chemistry, Biochemistry, Microbiology, or related field with 15+ years of experience, or Master of Science (M.Sc.) in a related discipline with 13+ years of experience, or PhD in Science with 10+ years of experience.
- At least 7 years of leadership/management experience.
- Technical and regulatory understanding and experience of biologics, gene, and/or cell therapy QC with an understanding of control strategy.
- Experience leading client site visits, audits, and regulatory inspections.
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Head of Quality Control
5 days ago
Mount Holly Springs, Pennsylvania, United States FUJIFILM Corporation Full timeOverviewFUJIFILM Diosynth Biotechnologies is seeking a highly skilled and experienced professional to lead our Quality Control team at our Holly Springs, North Carolina site. As the Senior Director of Quality Control, you will be responsible for providing strategic, technical, and operational leadership to the site Quality Control Laboratories.Key...
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Senior Director of Quality Control
8 hours ago
Holly Springs, NC , USA, United States FUJIFILM Corporation Full timeAbout the RoleFUJIFILM Diosynth Biotechnologies is seeking a highly skilled and experienced Senior Director of Quality Control to join our team in Holly Springs, North Carolina. As a key member of our site leadership team, you will be responsible for developing and implementing the quality control strategy for our new facility, ensuring compliance with...
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Quality Control Specialist
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